Tech Stack

Description

As a Regulatory Affairs Specialist (Sr. Product License Maintenance Manager), you will manage certificate requests, compile NDA Annual Reports, and submit Drug Listings to FDA. You'll work remotely for a global CRO, supporting a single sponsor while ensuring compliance with regulatory deadlines.

Requirements

• 3+ years regulatory experience
• Experience submitting US Annual Reports
• Proven ability to support international product approval
• Advanced Microsoft Office Suite skills
• Bachelor's degree (desirable or equivalent experience)

Responsibilities

• Review new certificate requests and forward to suppliers for processing
• Compile NDA Annual Reports and submit Drug Listings to FDA
• Manage multiple tasks to meet performance metrics and filing deadlines
• Liaise with stakeholders to collect information for certificate requests
• Coordinate legalization through Consular Services